Evaluation of a Smartphone Application for Self-help for Social Anxiety

Social Anxiety Clinical Trial

— SMASH  

Official title:

Evaluation of a Smartphone Application for Self-help for Patients With Social Anxiety Disorder: a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554718
• Other study ID #: SoPho-App-Evaluation
• Status: Recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: October 2023

Study information

• Verified date: September 2022
• Source: Goethe University
• Contact: Ulrich Stangier, Professor
• Phone: +49 69 - 798-22848
• Email: stangier[@]psych.uni-frankfurt.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study examines whether a self-help app can reduce symptoms of social anxiety disorder.

Description:

The study will test the effectiveness of a newly developed mobile app in treating patients with social anxiety. Participants will be randomly assigned to one of the following groups: app use only, therapist-guided app use, and a wait-list control group. Over a 12-week period, the study will examine whether mobile app use leads to significant reductions in symptoms associated with social anxiety, as well as improvements in secondary outcomes such as quality of life, depression, or psychological impairment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Current diagnosis of Social Anxiety Disorder
• Written informed consent before the start of the study
• Age: 18 to 65 years
• Possession of smartphone
• Familiarity with using smartphone apps

Exclusion Criteria:

• Acute suicidality
• Active substance abuse or dependence
• Severe medical conditions (e.g., chronic cardiovascular disease)
• Severe depression
• Psychotic disorder
• Bipolar disorder
• Borderline personality disorder
• Current psychotherapeutic treatment
• Current psychopharmacological treatment
• No proficient skills in the German language

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

Behavioral:
• Self-help Smartphone App
The app provides a 12-week adaptation of scientifically proven cognitive behavioral therapy techniques for the treatment of SAD and is intended for use as a mobile intervention. The app includes modules such as learning (e.g., creating a model, learning about the maintaining factors), changing the maintaining factors (e.g., safety behaviors), or behavioral experiments.
• Therapist-guided App Use
In addition to using the app, patients receive a total of 8 video-based therapy sessions over the course of 12 weeks. The sessions include topics such as video feedback and behavioral experiments.

Locations

Country	Name	City	State
Germany	Technische Universitaet Dresden	Dresden
Germany	Goethe Universitaet Frankfurt	Frankfurt

Sponsors (3)

Lead Sponsor	Collaborator
Goethe University	Mindable Health GmbH, Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in SAD-related symptom severity measured by the Liebowitz Social Anxiety Scale	The LSAS is a clinician-rated interview designed to measure fear and avoidance in different social situations. The situations are rated on scale from 0 ("not at all" or "never") to 3 (severe" or "most of the time"), with higher scores indicating greater symptoms of social anxiety.	change from baseline (week 0) to week 12 (post) and to week 36 (follow-up)
Secondary	Change in SAD-related symptoms measured by the Social Phobia Inventory (SPIN)	The SPIN is a self-report questionnaire designed to assess the amount of discomfort in different situations during the last week. The scale ranges from 0 ("not at all") to 4 ("extremely"). The total score ranges from 0 to 68, with higher scores indicating more severe symptoms of social anxiety.	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	Change in the Social Phobic Cognition Questionnaire (SPK)	The SPK lists 22 SAD-related beliefs that are rated on two scales: thought frequency, ranging from 1 ("thought never occurs") to 5 ("thought always occurs") and belief rating, ranging from 0 ("I do not believe this thought") to 100 ("I am completely convinced this thought is true"). Higher scores indicate more SAD-related beliefs.	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	Pain and Disability Index (PDI)	The PDI measures the amount of impairment and distress caused by the mental illness. It consists of 7 different categories (e.g., "Social Activity") that are rated on a scale fom 0 ("no disability") to 10 ("total disability"). Higher scores indicating higher levels of disability.	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	Beck Depression Inventory - Fast Screen (BDI-FS)	The BDI-FS assesses symptoms of depression using 7 items on a 4-point scale, with higher scores indicating greater severity.	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	World Health Organization Quality of Life (WHO-QOL-BREF)	The WHO-QOL-BREF measures the overall quality of life and asks for ratings on varying 5-point-scales for different domains like physical health (e.g., "how satisfied are you with..."). Scores for each domain are transformed to a scale of 0 to 100, with higher overall scores indicating a higher quality of life.	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	Brief Symptom Inventory - 18-item version (BSI-18)	The BSI measures general psychological distress using 18 items like "feelings of loneliness" on a scale from 0 ("not at all") to 4 ("a lot").	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)	The ACIPS measures the pleasure a person experiences in a social situation with a total of 17 items. The items are rated on a scale from 1 ("very false for me") to 6 ("very true for me"), with higher total scores indicating higher interpersonal pleasure.	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	Social Pain Questionnaire-5 (SPQ-5)	Sensitivity to rejection in social situations are assessed with the Social Pain Questionnaire (SPQ-5). The questionnaire consists of 5 items rating from 0 ("describes me perfectly") to 4 ("not at all"). Higher total scores indicate higher social pain.	baseline measurement only (week 0) before intervention starts
Secondary	Self-developed question regarding skills in using the Internet	A single question assesses participants' ability to use smartphone apps on a scale of 0 to 100, with higher scores indicating greater ability to use apps on the smartphone. We hypothesize that this variable could moderate the outcome effects.	baseline measurement only (week 0) before intervention starts
Secondary	self-developed question regarding the attitude towards online interventions	To assess a person's attitude toward online circumvention, a question is asked that is rated on a scale of 0 ("not helpful at all") to 100 ("extremely helpful"), with higher scores indicating higher positive expectations. We hypothesize that this variable could moderate the outcome effects.	baseline measurement only (week 0) before intervention starts
Secondary	Client Satisfaction Questionnaire (CSQ)	Treatment satisfaction will be measured by using the Client Satisfaction Questionnaire (CSQ), which we adapted slightly to match the use of the app. The questionnaire consists of 8 questions rated on a scale from 1 ("not at all") to 4 ("definitely yes").	Only post measurement (week 12)
Secondary	Self-developed questionnaire on negative effects of treatment	Drawing on the results of Boettcher et al., we developed a brief (7-item) scale with items covering the negative side effects that were considered most relevant by a group of experts. The items are rated on a scale from 0 ("do not agree at all") to 5 ("fully agree"). Please note, that the descriptive list of possible side effects is preliminary and may be slightly revised after the pilot study. As the list contains an open item, responses to this item will be evaluated after the pilot study and inclusion of further side effects in the list is possible should they be mentioned frequently.	Only post measurement (week 12)
Secondary	Clinical Global Impression (CGI)	The CGI-Severity scale provides information about the current severity of social phobic symptoms which are rated on a 7-step scale from "normal" or "not ill at all" to "among the most severely ill patients" by a clinician. The CGI-Improvement scale is a 7-point scale rating the change in symptom severity from 'improved by a lot' to 'a lot worse'. The use of the CGI, as a measure for symptom-specific improvement for patients with SAD, is supported by adequate psychometric properties and its practicability.	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	Quick Inventory of Depressive Symptoms (QIDS-C)	The Quick Inventory of Depressive Symptomatology (QIDS-C) is a 16-item rating instrument for the assessment of depressive symptoms by an independent interviewer.	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	Structured Clinical Interview for DSM 5 SCID-V-CV	Structured interview providing a formal diagnosis. Psychometric properties showed good reliability and specificity.	change from baseline to week 12 (post) and to week 36 (follow-up)
Secondary	Modified version of the Social Phobia Weekly Summary Scale (SPWSS)	Social anxiety and social approach behavior will be measured using a modified version of the Social Phobia Weekly Summary Scale (SPWSS). The individual points are rated on a scale from 0 to 100, with higher values indicating a higher rating of the respective item.	weekly questionnaire from baseline to week 12 (post), as well as assessments at baseline, 6 weeks (mid), 12 weeks (post), and 36 weeks (follow-up)